Accutrend Plus - University of Malta
Contents
1. UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT Ref No SOP PD 222_02 STANDARD OPERATING PROCEDURE Valid for ACCUTREND PLUS 2 years from approval Table of Contents rJ n ag Scope Objective Definitions Responsibility Procedure 5 1 Diagram of Accutrend Plus 5 2 Configuration 5 3 Operation 5 4 Storing Results 5 5 Quality Control 5 6 Maintenance 5 7 Troubleshooting 5 8 Flow Charts Precautions References Appendices Revision History BM de de pe rs C9 CM QN Un bh v9 t9 NII BN E Be ak IBY SS _ o NO MO SNO D YO Original 4 Ww Authorised Copy Reviewed by Fanio TEM A Signature Date Fott aale Lew M Ar adl Signature Date il h 2 14 j Approved by Page 1 of 20 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT Ref No SOP PD 222_02 STANDARD OPERATING PROCEDURE Valid for ACCUTREND PLUS 2 years from approval 1 Scope This Standard Operating Procedure SOP applies to the staff and students using Accutrend Plus in the laboratories of the Pharmacy Department University of Malta 2 Objective To describe the procedure for the configuration operation recording of results quality control maintenance and troubleshooting of Accutrend Plus 3 Definitions 3 1 Accutrend Plus2. used for quantitative measurement of blood glucose and blood cholesterol such tests are done using reflectance photometric measurements using test strips specific to each of the mentioned parameters 3 2 Code Strip A code chip supplied with each test strip container containing an imprinted barcode with lot specific information which is read and stored by the Accutrend Plus 3 3 Control Solutions Solutions used to perform a quality control check There are 2 different control solutions available i e for low level testing and for high level testing 3 4 Memory Mode A function that allows the storage of up to 100 different test results together with their relevant time and date Once this memory is full the device will start to automatically overwrite the oldest entries consecutively 3 5 Optical Measurement System The part of the device which uses light to quantitatively measure the glucose concentration in the blood It is located underneath the measurement optics cover 3 6 Set Mode Allows the device to be set according to the user s preferences 3 7 Test Strip A strip of sensitised material used in testing of bodily fluids 3 8 Test Strip Guide The area in which the test strip is inserted 4 Responsibility 4 1 The members of the Department of Pharmacy staff and students are responsible for following this SOP Page 2 of 20 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT Ref No
3. 1 2 Glucose 18 32 C Keep the device clean at all times see 5 6 Close the test strip container immediately after opening to maintain their shelf life Do not touch or remove test strip during measurement process Store test strip container together with the code strip in their appropriate external packaging If performing measurement for more than one patient refer to SOP Health and Safety POCT SOP PD 201_01 6 6 1 Use gloves Gloves are to be used always even when performing test for one person 6 6 2 Apply blood outside device using capillary pipettes 6 6 3 Dispose of used capillary pipettes and test strips in a sharps container Wash hands and rinse with plenty of clean water as creams and soaps contain fat which can yield an incorrect triglyceride result if present on test strip For cholesterol or triglycerides tests wipe the first drop of blood using a cellulose pad and use the second drop of blood 7 References Roche Diagnostics Accutrend Plus GmbH blood glucose cholesterol triglycerides and lactate meter monitor user s manual Mannheim Roche Diagnostics 2007 8 Appendices SOP PD 222 02 A1 Configuration Parameters Table 9 Revision History Version Number Amendments Reasons for change 01 Initial Release 02 Inclusion of subheading titles of Procedure section in Table of Contents Page 19 of 20 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp
4. FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT STANDARD OPERATING PROCEDURE Ref No SOP PD 222 02 ACCUTREND PLUS Valid for 2 years from approval 5 8 2 2 Performing a measurement Wait for flashing test strip symbol to be displayed Remove test strip from storage container and replace cap tightly Check back of test strip for discolouration Test strip is unusable Hold test strip so that application area is facing upwards Insert test strip into test strip guide Wait for 2 consecutive beeps to indicate correct positioning Open measurement chamber flap Wait for flashing drop symbol to be displayed Glucose or Cholesterol reading No Glucose Cholesterol Wipe away first drop of blood Apply blood drop against yellow sampling area Page 12 of 20 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT Ref No SOP PD 222_02 STANDARD OPERATING PROCEDURE Valid for ACCUTREND PLUS 2 years from approval Close measurement chamber flap to initiate measurement process Glucose Wait 12 seconds Glucose or Cholesterol reading Cholesterol Wait 180 seconds Wait for final long beep as sign of completion of test Glucose Perform a Plausibilitv check Glucose or Cholesterol reading Cholesterol Remove test strip to compare reaction area at the bottom o
5. SOP PD 222_02 STANDARD OPERATING PROCEDURE Valid for ACCUTREND PLUS oer approval 4 2 The designated Laboratory Officer or Laboratory Assistant is responsible for ensuring that this SOP is followed 5 Procedure 5 1 Diagram of Accutrend Plus A Display B M Button memory C On Off button D Measurement chamber flap E Test Strip guide F Set button G Battery compartment lid H Measurement chamber cover Page 3 of 20 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT Ref No SOP PD 222_02 STANDARD OPERATING PROCEDURE Valid for ACCUTREND PLUS 2 years from approval 5 2 5 3 Configuration 5 2 1 Insert 4 AAA 1 5 alkaline batteries 5 2 2 Press the On Off button to switch the device On 5 2 3 Hold the On Off button when the device is switched On to perform a display test Display test is shown for the time the button is held 5 2 4 Check that the last stored code is displayed at the end of the display test 5 2 5 Press the SET button to enter SET mode 5 2 6 Refer to SOP PD 222_02 A1 to set up each parameter in the set up menu Operation 5 3 1 Inserting code strip 5 3 1 1 Hold the code strip from its white area at the bottom avoiding the printed area 5 3 1 2 Insert the code strip into the test strip guide 5 3 1 3 Stop at the end of directional arrows printed on code strip 5 3 1 4 Withdraw co
6. SURGERY PHARMACY DEPARTMENT Ref No STANDARD OPERATING PROCEDURE SOP PD 222_02 ACCUTREND PLUS 2 years from Valid for approval SOP PD 222 02 A1 Configuration Parameters Table Configuration Display Set Up parameter Symbol Date and Time XX XX XX Press SET button to power on in SET mode format Press SET button again to make changes in SET mode Press M button to change between date formats Press SET button to save format and set date Press M button to set the year Press SET button to save displayed year Press M button to set the month Press SET button to save displayed month Press M button to set the day Press SET button to save displayed day and SET time format Press M button to change time format Press SET button to save time format and SET time Press M button to set the hour Press SET button to set minutes Press SET button to save displayed time and SET Beeper Beeper Press M button to switch between off and On default Press SET button to save the selected setting x denotes any number Page 20 of 20
7. a new test strip after blood application Switch device Off rc Internal error Switch device On C f f example Error 142 Clean device as described in 5 6 If error persists contact supplier Page 9 of 20 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT STANDARD OPERATING PROCEDURE Ref No SOP PD 222 02 ACCUTREND PLUS Valid for 2 years from approval Flow Charts Configuration Insert 4 AAA 1 5 alkaline batteries Press On Off button to switch device On Hold the On Off button to perform a display test shown for the time the button is held Check that last stored code is displayed at the end of the display test Press SET button to enter Set mode Refer to SOP PD 222_02 A1 to set up each parameter Page 10 of 20 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT Ref No SOP PD 222_02 STANDARD OPERATING PROCEDURE Valid for ACCUTREND PLUS 2 years from approval 5 8 2 Operation 5 8 2 1 Inserting code strip Hold code strip from its white area Insert code strip into test strip guide Stop at the end of directional arrows Withdraw code strip and leave measurement chamber flap closed Wait for short beep to confirm successful coding Y 3 digit code printed on code strip is shown on display Page 11 of 20 UNIVERSITY OF MALTA
8. de strip and leave measurement chamber flap closed 5 3 1 5 Wait for a short beep to be heard to confirm that coding was successful 5 3 1 6 Wait for the 3 digit code that is printed on the code strip to be displayed 5 3 2 Performing a measurement 5 3 2 1 Wait for a flashing test strip symbol to be displayed 5 3 2 2 Remove a test strip from its storage container and replace its cap tightly 5 3 2 3 Check back of test strip for discolouration Discard test strip if discoloured 5 3 2 4 Hold test strip so that application area is facing upwards 5 3 2 5 Insert test strip into test strip guide Wait for 2 consecutive beeps to be heard to indicate that the test strip has been positioned correctly 5 3 2 6 Open the measurement chamber flap 5 3 2 7 Wait for a flashing drop symbol to be displayed 5 3 2 8 To perform a glucose reading immediately apply a drop of blood against the yellow sampling area Page 4 of 20 FACULTY OF MEDICINE amp SURGERY UNIVERSITY OF MALTA PHARMACY DEPARTMENT Ref No STANDARD OPERATING PROCEDURE SOP PD 222_02 Valid for ACCUTREND PLUS 2 years from approval 5 3 2 9 5 3 2 10 5 3 2 11 5 3 2 12 5 3 2 13 5 3 2 14 5 3 2 15 5 3 2 16 5 3 2 17 5 3 2 18 To perform a cholesterol reading wipe the first drop of blood and apply the second drop of blood to the yellow sampling area Close measurement chamber flap to initiate
9. eter is empty is stored incorrectly End Page 15 of 20 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT STANDARD OPERATING PROCEDURE Ref No SOP PD 222 02 ACCUTREND PLUS Valid for 2 years from approval 5 8 3 Quality Control Hold power button whilst powering on to perform display test Arrange Displayed accordingly see date and SOP PD 222_02 time correct a Al Battery symbol displaved No Yes Change batteries Remove test strip from container and replace cap tightly Insert test strip into test strip guide application area facing upwards Wait for two consecutive beeps Press M button to flag measurement as control Open measurement chamber flap until it locks into a vertical position Page 16 of 20 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT Ref No SOP PD 222_02 STANDARD OPERATING PROCEDURE Valid for ACCUTREND PLUS 2 years from approval HIGH level or LOW level control solution HIGH LOW Apply drop of control solution Close chamber flap to start measurement Glucose or Cholesterol LOW level control solution Glucose or Cholesterol HIGH level control solution Glucose Glucose Wait 12 seconds Wait 12 seconds Cholesterol Cholesterol Wait 180 seconds Wait 180 seconds Wait for final long beep for co
10. f strip with scale on test container Abnormal Abnormal or normal value Perform quality control Normal test using new test strip see 5 8 3 Page 13 of 20 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT Ref No SOP PD 222_02 STANDARD OPERATING PROCEDURE Valid for ACCUTREND PLUS 2 years from approval Flagging required To flag as Control or Event Control Press M button Press SET button to increase value from 0 to 9 Press SET button Open measurement chamber flap and remove test strip Discard test strip and lancet in sharps container Press On Off button to turn device off Page 14 of 20 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT Ref No SOP PD 222_02 STANDARD OPERATING PROCEDURE Valid for ACCUTREND PLUS 2 years from approval 5 8 2 3 Storing Results Hold M button to switch on in memory mode Wait for mem to be displayed to indicate that device is in memory mode Press SET button to switch between the two test parameters Wait for last stored value to be displayed Press M to display first value Hold M button pressed to cycle through older readings in memory Three dashes displayed One dash displayed Two dashes displayed Memory is empty Memory of test Single measurement param
11. measurement process Wait for a test evaluation time of approximately 12 seconds to perform a glucose reading Wait for a test evaluation time of approximately 180 seconds to perform a cholesterol reading Wait for a final long beep to indicate completion of measurement Perform a plausibility test see 5 3 3 if a glucose measurement is being performed Displayed reading falls outside the measurement range if a Hi or Lo symbol is indicated Refer to 5 3 4 if flagging of result is required Open the measurement chamber flap and remove test strip Discard the test strip and lancet in the sharps container Press On Off button to turn the device Off 5 3 3 Plausibility check after glucose measurement 5 3 3 1 5 1 3 2 5 3 4 5 3 4 1 5 3 4 2 5 3 4 3 Remove test strip and compare the reaction area at the bottom of the test strip with the scale present on the label of the test strip container Perform a quality control test if result is unusually high or low as per 5 5 Flagging a measurement Press the M button if measurement is to be labelled as a control Press SET button if measurement is to be labelled as an event Press SET button to increase event value from Zero 0 to Nine 9 5 4 Storing Results 5 4 1 5 4 2 5 4 3 5 4 4 5 4 5 Hold the M button to switch on the device in memory mode Wait for mem symbol to be displayed to indicate that the device instrument is in memory mode Wait fo
12. mpletion Check if displayed result corresponds to range indicated by label or package insert Discard test strip and lancet in sharps container Press On Off button to turn device Off Page 17 of 20 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT STANDARD OPERATING PROCEDURE Ref No SOP PD 222 02 ACCUTREND PLUS Valid for 2 years from approval 5 8 4 Maintenance Hold On Off button to turn device On in display test mode Check Date and Time are correct Check batteries if battery symbol is displayed Switch device Off Clean outside surface with a moist cloth and mild cleaning agent Open measurement chamber flap Push forwards and upwards the test strip guide to remove it Rinse test strip guide and dry using clean cloth Clean optical measuring system using lint free pad and allow drying Press down slightly the test strip guide until it clicks into place Close measurement chamber flap Perform quality control check see 5 5 Page 18 of 20 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT Ref No SOP PD 222_02 STANDARD OPERATING PROCEDURE Valid for ACCUTREND PLUS 2 years from approval 6 Precautions 6 1 6 2 6 3 6 4 6 5 6 6 6 7 6 8 Operate the device under the following test specific temperatures 6 1 1 Cholesterol 18 30 C 6
13. nds to perform a glucose reading 5 5 9 Wait for a test evaluation time of approximately 180 seconds to perform a cholesterol reading 5 5 10 Wait for a final long beep to indicate completion of measurement 5 5 11 Check if displayed result falls within the acceptable range found on labels package insert of test strips or control solution 5 5 12 Repeat 5 5 4 5 5 11 using either glucose or cholesterol high level control solution Maintenance 5 6 1 Hold the On Off button to turn On the device to perform a display test 5 6 2 Check that date and time are correct 5 6 3 Change batteries if battery symbol is displayed 5 6 4 Check that the device is switched Off Page 6 of 20 FACULTY OF MEDICINE amp SURGERY UNIVERSITY OF MALTA PHARMACY DEPARTMENT Ref No STANDARD OPERATING PROCEDURE SOP PD 222_02 Valid for ACCUTREND PLUS 2 years from approval 5 6 5 5 6 6 5 6 7 5 6 8 5 6 9 5 6 10 5 6 11 5 6 12 5 6 13 Clean the outside of the device with a moist cloth and a mild cleaning agent Check that the device is switched Off Open the measurement chamber flap Remove the test strip guide by simultaneously pushing forward and upwards gently Rinse test strip guide and dry using a clean cloth Clean the optical measuring system using a lint free pad or lightly moistened cotton ball and allow drying Replace test strip guide by pressing it down slightly un
14. r the last stored value to be displayed Press SET button to switch between the two test parameters of each memory area Glucose or Cholesterol Press M button to display the next value Page 5 of 20 FACULTY OF MEDICINE amp SURGERY UNIVERSITY OF MALTA PHARMACY DEPARTMENT Ref No STANDARD OPERATING PROCEDURE SOP PD 222_02 Valid for ACCUTREND PLUS 2 years from approval 5 5 5 6 5 4 6 Press and hold the M button to cycle through older readings in memory 5 4 7 If entire memory is empty three dashes will be displayed 5 4 8 If entire memory area of a test parameter is empty two dashes will be displayed 5 4 9 If a single measured value is stored incorrectly one dash will be displayed 5 4 10 Press the On Off button to exit memory mode Quality Control 5 5 1 Remove a test strip from its storage container and replace its cap tightly 5 5 2 Hold test strip so that application area is facing upwards 5 5 3 Insert test strip into the test strip guide Two consecutive beeps are heard if test strip was inserted correctly 5 5 4 Press the M button to flag measurement as a control 5 5 5 Open measurement chamber flap until it locks into a vertical position 5 5 6 Apply a drop of either glucose or cholesterol low level control solution 5 5 7 Close the measurement chamber flap to initiate measurement process 5 5 8 Wait for a test evaluation time of approximately 12 seco
15. til it clicks into place Close the measurement chamber flap Perform a quality control test see 5 5 Page 7 of 20 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT Ref No SOP PD 222 02 STANDARD OPERATING PROCEDURE ACCUTREND PLUS Valid for 2 years from approval 5 7 Troubleshooting Display Message Cause s Solution s code Check that barcode is not tainted with dirt Unknown barcode Repeat test with new test strip Keep device away from electromagnetic sources code Test strip code does not Repeat using test strip with match stored code matching code Unusable test strip Repeat test using new test strip LA Temperature is not within acceptable limits Move device to an area with an acceptable temperature range Page 8 of 20 UNIVERSITY OF MALTA FACULTY OF MEDICINE amp SURGERY PHARMACY DEPARTMENT Ref No SOP PD 222_02 STANDARD OPERATING PROCEDURE Valid for ACCUTREND PLUS 2 years from approval amp Measurement chamber flap not properly closed Close measurement chamber flap after device has been appropriately switched On amp gt A Measurement chamber flap not properly closed during measurement Close measurement chamber flap appropriately Measurement chamber f g sec Remove test strip and repeat test flap not properly closed i using
Download Pdf Manuals
Related Search